Clinical trial · Interventional
Local Non-salvage Radiotherapy for Synchronous Oligometastatic Non-small-cell Lung Cancer.
Local Non-salvage Radiotherapy for Synchronous Oligometastatic Non-small-cell Lung Cancer :A Multicenter,Randomized,Controlled,Phase 2 Study.
NCT03119519CI-TRIAL-00044093unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Aggressive therapy may improve survival in synchronous oligometastatic NSCLC and the goal of this clinical trial is to assess the efficacy and safety of local definitive radiotherapy in this subset of patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IV Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Local Definitive Radiotherapy | Radiation | — | UNRESOLVED |
| No Local Definitive Radiotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Local Definitive Radiotherapy
- description
- Standard platinum-based doublet chemotherapy or EGFR-TKI (Gefitinib or Erlotinib) followed by 3D-CRT (three-dimensional conformal radiotherapy) or IMRT (intensity modulated radiotherapy) to primary thoracic foci or remediable oligometastatic focus.
- interventionNames
- Radiation: Local Definitive Radiotherapy
- Drug: No Local Definitive Radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- No Local Definitive Radiotherapy
- description
- Standard platinum-based doublet chemotherapy or EGFR-TKI (Gefitinib or Erlotinib) alone, according to gene test.
- interventionNames
- Drug: No Local Definitive Radiotherapy
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female aged 18 to 70 years old; 2. Histologically or cytologically confirmed non-small cell lung cancer; 3. Stage IV patients with measurable primary tumor and distant metastases number ≤5； 4. PS score 0-2； 5. Have never received local or systemic anti-cancer treatment, including surgery (biopsy is allowed), first line chemotherapy, targeted therapy or immunotherapy; 6. Life expectancy of \>3 months; 7. Organ function levels must meet the following requirements: (1)Bone marrow: White blood cell (WBC)≥4.0G/L；neutrophile granulocyte (NEU)≥1.5G/L；platelets (PLT)≥100G/L; hemoglobin (HGB)≥9g/L； (2)Liver and kidney: total bilirubin (TBIL), aspartate aminotransferase (AST), alanine aminotransferase (ALT)≤2.0 × the upper limit of normal (ULN)；creatinine≤1.5×ULN; 8.Patient must be willing and able to provide written informed consent. Exclusion Criteria: 1. The amount of metastatic focus \>5; 2. Patient can't tolerate chemotherapy or targeted therapy; 3. Local or systemic anti-cancer treatment had been used for the primary foci and metastatic lymph nodes, including surgery (biopsy is allowed), first line chemotherapy, targeted therapy or immunotherapy; 4. Previous or concurrent suffered from other malignancies; 5. Concurrent with other serious disease that can not be controlled; 6. Women who are breast-feeding or pregnant; 7. Have an allergy to pemetrexed, cisplatin, taxanes, targeted medicine and contrast agent; 8. Patients with poor obedience or researchers think that the patient may not be able to accomplish the whole trial.
References
Publications (0)
Data not yet available
No reference posted for this study.